Jagtome™ Revolution Pro RX 39 M00584470

GUDID 00191506039318

Cannulating Sphincterotome

BOSTON SCIENTIFIC CORPORATION

ERCP catheter, non-balloon, electrosurgical

• Primary Device ID: 00191506039318
• NIH Device Record Key: 34dbcded-735d-48cd-ae5e-d6797cdec308
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jagtome™ Revolution Pro RX 39
• Version Model Number: M00584470
• Catalog Number: M00584470
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506039318 [Primary]

FDA Product Code

• KNS: Unit, electrosurgical, endoscopic (with or without accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-02
• Device Publish Date: 2023-10-25

On-Brand Devices [Jagtome™ Revolution Pro RX 39]

• 00191506039325: Cannulating Sphincterotome
• 00191506039318: Cannulating Sphincterotome